Status:
COMPLETED
BSCU1 and Immune Function
Lead Sponsor:
Lesaffre International
Collaborating Sponsors:
NIZO Food Research
Conditions:
General Population
Eligibility:
All Genders
3-79 years
Phase:
NA
Brief Summary
The current study aims to explore a range of possible pathways by which BSCU1 could beneficially modulate the immune system, in three target populations representing the general population.
Detailed Description
This exploratory study is designed as a single-arm study with repeated measures, involving three different populations, in which each subject serves as its own control. The duration of the interventio...
Eligibility Criteria
Inclusion
- Adults
- 30 ≤ age ≤ 49 years
- BMI ≥ 18.5 and ≤ 25 kg/m2
- In good health as assessed during screening (by questionnaire), and the medical investigator's professional judgment
- Non-smoking
- Elderly
- 65 ≤ age ≤ 79 years
- BMI ≥ 22.0 and ≤ 28.0 kg/m2
- Generally healthy as assessed during screening (by questionnaire), and the medical investigator's professional judgment
- Non-smoking
- Children
- 3 ≤ age ≤ 6 years
- Healthy BMI, cut-off points will be used as indicated by JGZ
- Generally healthy as assessed during screening (by parental anamnesis), and the study physician's professional judgment
Exclusion
- Adults and elderly
- Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease),
- Acute infection in the past month
- Gastrointestinal disorders (e.g., inflammatory bowel disease),
- Acute gastroenteritis in the past 2 months
- Any vaccination in the past month or any scheduled vaccination during the study period
- Treatment with antibiotics within 2 months before the start of the study and during the study period
- Regular use of laxative agents
- Immunodeficiency disorder
- Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
- Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening
- Regular consumption of probiotics within 1 month before start of the study
- Evidence of current excessive alcohol consumption (\>4 consumptions/day or \>20 consumptions/week) or drug (ab)use
- Mental status that is incompatible with the proper conduct of the study
- Children
- Acute respiratory or gastrointestinal infection in the past month
- Chronic illness (e.g. chronic infections, systemic or metabolic disease)
- Gastrointestinal disorders (e.g., inflammatory bowel disease),
- Acute gastroenteritis in the past 2 months
- Any vaccination in the past month or any scheduled vaccination during the study period
- Treatment with antibiotics within 2 months before the start of the study and during the study period
- Immunodeficiency disorder
- Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
- Regular use of laxative agents
- Regular consumption of probiotics within 1 month before start of the study
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05403398
Start Date
June 7 2022
End Date
March 20 2023
Last Update
January 8 2024
Active Locations (1)
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1
NIZO food research BV
Ede, ZB, Netherlands, 6718